(76 days)
No reference devices were used in this submission.
No
The summary describes image processing and quantification tools based on MR physics, but there is no mention of AI, ML, or related concepts like training data or algorithms that learn from data.
No
The device is described as an "aid to diagnosis" and provides "information that may assist in diagnosis." It does not directly provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis." Additionally, the "Device Description" section explicitly says, "LiverMultiScan (LMSv2) is an aid to diagnosis." These statements clearly indicate the device's role in the diagnostic process.
Yes
The device description explicitly states that LiverMultiScan (LMSv2) is a "standalone software application" that runs on a "general purpose workstation." It processes existing MR image data and does not include or require any specific hardware components beyond the standard computer setup.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: LiverMultiScan (LMSv2) is a software application that processes magnetic resonance medical image data acquired from an MR scanner. It analyzes images of the liver and abdomen to quantify tissue characteristics.
- Input Data: The input data is imaging data (DICOM MR images), not biological samples from the body.
- Purpose: The purpose is to provide information derived from imaging that assists in diagnosis when interpreted by a trained clinician. It does not directly perform a test on a biological sample.
Therefore, LiverMultiScan (LMSv2) falls under the category of medical imaging software or image processing software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
LiverMultiScan (LMSv2) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LiverMultiScan (LMSv2) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LiverMultiScan (LMSy2) provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
LiverMultiScan (LMSv2) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from compatible MR Scanners. LiverMultiScan runs on a general purpose workstation with a colour monitor, keyboard and mouse. LiverMultiScan (LMSv2) is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the operator may also create, display, print, store and distribute reports resulting from interpretation of the datasets.
LiverMultiScan (LMSv2) allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.
LiverMultiScan (LMSv2) provides a number of tools, such as circular region of interest placements, to be used for the assessment of regions of an image to support a clinical workflow.
LiverMultiScan (LMSv2) allows the operator to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat.
LiverMultiScan (LMSv2) is intended to be used by trained operators. Reports generated by trained operators are intended for use by interpreting clinicians, including, but not limited to radiologists, gastroenterologists, and hepatologists.
LiverMultiScan (LMSv2) is an aid to diagnosis. When interpreted by a trained clinician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows.
LiverMultiScan (LMSv2) offers the following.
- Advanced visualisation of MR data.
- Processing of MR data to quantify tissue characteristics including MR relaxivity constants such as T2*, T1, ironcorrected T1 (cT1) and triglyceride fat fraction (expressed as liver fat percentage).
- Circular region of interest statistics.
- Snapshot of images to include in a report.
- Report to include region statistics, snapshot images and user-entered text.
- Export of snapshot images to report.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Abdomen, Liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Device User: Trained operator
Report User: Interpreting clinician (radiologists, gastroenterologists, and hepatologists)
Care Setting: Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Summary of Performance Studies:
Substantial equivalence performance testing, head-to-head evaluation of the subject and predicate devices' ability to measure (corrected) T1, T2* and PDFF using phantoms as well as in-vivo volunteer data.
Key Metrics for phantom:
-
T1 Accuracy 95% CI Limits of Agreement: 19-25% lower than ground truth
-
T2* Accuracy 95% CI Limits of Agreement: +/- 2ms
-
PDFF = 30% Accuracy 95% CI Limits of Agreement: +/- 21%
-
T1 Repeatability 95% Cl Limits of Agreement: +/- 10ms
-
T2* Repeatability 95% Cl Limits of Agreement: +/- 1.7ms
-
PDFF = 30% Repeatability 95% Cl Limits of Agreement: +/- 5%
-
T1 Reproducibility 95% Cl Limits of Agreement: -34 to 27ms
-
T2* Reproducibility 95% Cl Limits of Agreement: +/- 4ms
-
PDFF = 30% Reproducibility 95% Cl Limits of Agreement: +/-10 %
Key Metrics for in vivo:
-
cT1 Repeatability 95% Cl Limits of Agreement: +/- 60ms
-
T2* Repeatability 95% Cl Limits of Agreement: +/- 7ms
-
PDFF Repeatability 95% Cl Limits of Agreement: +/- 1%
-
cT1 Reproducibility 95% CI Limits of Agreement: +/- 120ms
-
T2* Reproducibility 95% CI Limits of Agreement: +/- 10ms
-
PDFF Reproducibility 95% CI Limits of Agreement: +/- 2%
-
cT1 Intra-operator 95% CI Limits of Agreement: +/- 18ms
-
T2* Intra-operator 95% CI Limits of Agreement: +/- 3ms
-
PDFF Intra-operator 95% CI Limits of Agreement: +/- 1%
-
cT1 Inter-operator 95% CI Limits of Agreement: +/- 25ms
-
T2* Inter-operator 95% CI Limits of Agreement: +/- 4ms
-
PDFF Inter-operator 95% CI Limits of Agreement: +/- 1.1%
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence performance testing will consist of a head-to-head evaluation of the subject and predicate devices' ability to measure (corrected) T1, T2* and PDFF using phantoms as well as in-vivo volunteer data.
For each of the comparisons, the following will be calculated:
- Mean difference in T1/ T2* and PDFF (magnitude of the bias)
- Standard deviation
- Bland-Altman 95% limits of agreement
- Slope of bias
Phantom:
The performance of LMSv2 demonstrates that:
- The MOLLI-based T1 measurement produced by LMSv2 is consistent with the literature-reported underestimation of ground truth T1 using MOLLI techniques.
- LiverMultiScan (LMSv2) measurement of T2* is accurate over the expected physiological range of values.
- LiverMultiScan (LMSv2) measurement of PDFF is accurate over the expected physiological range of values.
- LiverMultiScan (LMSv2) measurement of T1 is highly repeatable.
- LiverMultiScan (LMSv2) measurement of T1 is both repeatable within the same system and reproducible between systems.
- LiverMultiScan (LMSv2) measurement of T2* is highly repeatable.
- LiverMultiScan (LMSv2) measurement of T2* is both repeatable within the same system reproducible between systems at the same field strength.
- LiverMultiScan (LMSv2) measurement of PDFF is highly repeatable.
- LiverMultiScan (LMSv2) measurement of PDFF is reproducible between systems.
In Vivo:
The in vivo performance testing of LMSv2 demonstrates that:
- LiverMultiScan (LMSv2) measurement of cT1 is highly repeatable.
- LiverMultiScan (LMSv2) measurement of cT1 is reproducible between systems.
- LiverMultiScan (LMSv2) measurement of T2* is highly repeatable.
- LiverMultiScan (LMSv2) measurement of T2* is reproducible between systems at the same field strength.
- LiverMultiScan (LMSv2) measurement of PDFF is highly repeatable.
- LiverMultiScan (LMSv2) measurement of PDFF is reproducible between systems.
The variation introduced by operator reading (use of LMSv2) is well within the proscribed acceptance criteria. There is only minor additional variation introduced by having two readers read the same study compared to the same reader performing a second analysis blinded.
Substantial Equivalence (LMSv2 vs LMSv1):
Phantom measurements show that LMSv2 produces T1 and T2* values within 1ms of the predicate (negligible difference). PDFF is within 1% of the predicate where PDFF = 30% Phantom Equivalence 95% CI Limits of Agreement: -1.6 to 2%
In vivo measurements show that cT1 values produced by LMSv2 lie within 40ms of the predicate device, with T2* values within 1ms. There is negligible difference in the measurement of PDFF between LMSv2 and the predicate.
- cT1 In vivo Equivalence 95% CI Limits of Agreement: -14.8 to 40ms
- T2* In vivo Equivalence 95% CI Limits of Agreement: -0.5 to 0.8ms
- PDFF In vivo Equivalence 95% CI Limits of Agreement: -0.4 to 0.2%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. See "Summary of Performance Studies" for metrics listed.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
November 21, 2017
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Perspectum Diagnostics Ltd. % Jaco Jacobs Chief Compliance Officer 23-38 Hythe Bridge Street Oxford. Oxfordshire OX1 2ET UNITED KINGDOM
Re: K172685
Trade/Device Name: LiverMultiScan Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 1, 2017 Received: September 6, 2017
Dear Jaco Jacobs:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sincerely,
Michael D. O'Hara
For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172685
Device Name LiverMultiScan (LMSv2)
Indications for Use (Describe)
LiverMultiScan (LMSv2) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LiverMultiScan (LMSv2) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LiverMultiScan (LMSy2) provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.
| Type of Use (Select one or both, as applicable) |
|---|
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter
| Name: | Perspectum Diagnostics Ltd |
|---|---|
| Address: | Perspectum Diagnostics Ltd |
| 23-38 Hythe Bridge Street | |
| Oxford | |
| OX1 2ET | |
| United Kingdom | |
| Contact Person: | Dr. Jaco Jacobs |
| Date Prepared: | 1st September 2017 |
| 2. Subject Device | |
| Name of Device: | LiverMultiScan (LMSv2) |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Regulation: | 21 CFR 892.1000 |
| Regulatory Class: | Class II |
| Product Classification Code: | LNH |
| 3. Predicate Device | |
| Name of predicate device: | LiverMultiScan (LMSv1) |
| Predicate Manufacturer: | Mirada Medical Ltd |
| Oxford Centre for Innovation | |
| New Road | |
| Oxford | |
| OX1 1BY | |
| United Kingdom | |
| Predicate Trade Name: | LiverMultiScan |
4. Reference Device
No reference devices were used in this submission.
5. Device Description
LiverMultiScan (LMSv2) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from compatible MR Scanners. LiverMultiScan runs on a general purpose workstation with a colour monitor, keyboard and mouse.
4
Image /page/4/Picture/1 description: The image contains the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, dark gray font, with the word "Diagnostics" written in a lighter gray font underneath. To the right of the text is a circular graphic with four colored sections: blue, yellow, green, and pink. The pink section is split in half by a white line.
LiverMultiScan (LMSv2) is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the operator may also create, display, print, store and distribute reports resulting from interpretation of the datasets.
LiverMultiScan (LMSv2) allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.
LiverMultiScan (LMSv2) provides a number of tools, such as circular region of interest placements, to be used for the assessment of regions of an image to support a clinical workflow.
LiverMultiScan (LMSv2) allows the operator to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat.
LiverMultiScan (LMSv2) is intended to be used by trained operators. Reports generated by trained operators are intended for use by interpreting clinicians, including, but not limited to radiologists, gastroenterologists, and hepatologists.
LiverMultiScan (LMSv2) is an aid to diagnosis. When interpreted by a trained clinician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows.
LiverMultiScan (LMSv2) offers the following.
- ു Advanced visualisation of MR data.
- C Processing of MR data to quantify tissue characteristics including MR relaxivity constants such as T2*, T1, ironcorrected T1 (cT1) and triglyceride fat fraction (expressed as liver fat percentage).
- Circular region of interest statistics.
- Snapshot of images to include in a report.
- Report to include region statistics, snapshot images and user-entered text.
- Export of snapshot images to report.
6. Indications for Use
"LiverMultiScan (LMSv2) is indicated for use as a magnetic resonance diagnostic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.
LiverMultiScan (LMSv2) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.
LiverMultiScan (LMSv2) provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.
These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis."
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Image /page/5/Picture/1 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, dark gray font. Below it, the word "Diagnostics" is written in a lighter gray font. To the right of the text is a circular logo with four colored sections: yellow, blue, green, and pink.
7. Comparison to Predicate
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence.
Overview
The subject device is substantially equivalent to the predicate device, both regulated under regulation 21 CFR 892.1000, Magnetic Resonance Diagnostic Device.
- C The indications for use and intended uses of both the subject device and predicate device are equivalent.
- The subject device and predicate device both support multi-slice MR data acquired using the specific acquisition protocols, from supported MR Systems, to acquire the input data.
- The subject and predicate devices include software applications which utilise MR data to visualise and enable quantification of physiological characteristics in the liver to provide measurements which may be used to aid diagnosis.
- C The subject and predicate devices are both standalone software applications to facilitate the import and visualization of MR data sets.
- 3 Both the subject and predicate devices are designed to run on general-purpose computers.
- G Both the subject device and the predicate device include applications to facilitate the import and visualization of MR data sets and include tools to enable the manipulation of the views and to enable the quantification and analysis of tissue characteristics in the liver from the MR data.
- a The subject and predicate devices enable the quantification of analysis of tissue characteristics in the liver from the MR data.
- The subject and predicate devices use the same algorithmic specifications to support quantitative analysis.
- G The subject and predicate devices both support region of interest measurements derived from MR images and parametric maps of tissue characteristics.
- The subject and predicate devices facilitate the creation of a medical report containing the images and analysis output derived from quantification of liver tissue parameters.
- G The subject and predicate device reports all include tabular display of quantification statistics, parametric map images and include normal range references.
- © Performance testing demonstrates that the subject device performs at least as safely and effectively as the proposed predicate.
| Characteristic | LMSv2 (Subject) | LMSv1 (Predicate) |
|---|---|---|
| 510(k) | Not known | K143020 |
| Regulation | 21 CFR 892.1000 | 21 CFR 892.1000 |
| Regulatory Class | Class II | Class II |
| Product Code | LNH | LNH |
| Manufacturer | Perspectum Diagnostics Ltd | Mirada Medical Ltd |
| Intended Use and | ||
| Indications for Use | LiverMultiScan is indicated for use as | |
| magnetic resonance diagnostic device | ||
| software application for non-invasive liver | ||
| evaluation that enables the generation, | ||
| display and review of 2D magnetic resonance | ||
| medical image data and pixel maps for MR | ||
| relaxation times. | LMS is indicated for use as magnetic | |
| resonance diagnostic device software | ||
| application for non-invasive liver evaluation | ||
| that enables the generation, display and | ||
| review of 2D magnetic resonance medical | ||
| image data and pixel maps for MR relaxation | ||
| times. | ||
| LiverMultiScan is designed to utilize DICOM | ||
| 3.0 compliant magnetic resonance image | ||
| datasets, acquired from compatible MR | ||
| Systems, to display the internal structure of | ||
| the abdomen including the liver. Other | ||
| physical parameters derived from the images | ||
| may also be produced. | ||
| LiverMultiScan provides a number of | ||
| quantification tools, such as Region of | ||
| Interest (ROI) placements, to be used for the | ||
| assessment of regions of an image to | ||
| quantify liver tissue characteristics, including | ||
| the determination of triglyceride fat fraction | ||
| in the liver, T2* and iron-corrected T1 | ||
| measurements. | LMS is designed to utilize DICOM 3.0 | |
| compliant magnetic resonance image | ||
| datasets, acquired from Siemens MAGNETOM | ||
| Skyra MR Scanners, to display the internal | ||
| structure of the abdomen including the liver. | ||
| Other physical parameters derived from the | ||
| images may also be produced. | ||
| LMS provides a number of quantification tools | ||
| such as rulers and region of interest to be | ||
| used for the assessment of regions of an | ||
| image to support existing clinical workflows. | ||
| These images and the physical parameters | ||
| derived from the images, when interpreted | ||
| by a trained clinician, yield information that | ||
| may assist in diagnosis. | These images and the physical parameters | |
| derived from the images, when interpreted by | ||
| a trained physician, yield information that may | ||
| assist in diagnosis. | ||
| Target Population | Patients suitable to undergo an MRI scan and | |
| not contra-indicated for MRI. | Patients suitable to undergo an MRI scan and | |
| not contra-indicated for MRI. | ||
| Device User | Trained operator | Trained clinician |
| Report User | Interpreting clinician | Interpreting clinician |
| Anatomical | ||
| Location | Abdomen, Liver | Abdomen, Liver |
| Energy | ||
| Considerations | Software only application. The device, a | |
| standalone software application, does not | ||
| deliver or depend on energy delivered to or | ||
| from patients. | Software only application. The device, a | |
| standalone software application, does not | ||
| deliver or depend on energy delivered to or | ||
| from patients. | ||
| Design: Purpose | Standalone software application to facilitate | |
| the import and visualization of MR data sets | ||
| encompassing the abdomen, including the | ||
| liver with functionality independent of the | ||
| MRI equipment vendor. | ||
| Software application intended to display and | ||
| visualize 2D multi-slice, spin-echo MR data | ||
| sets encompassing the abdomen. The user | ||
| may process, and review DICOM 3.0 | ||
| compliant datasets within the system and/or | ||
| across computer networks. | Standalone software application to facilitate | |
| the import and visualization of MR data sets | ||
| encompassing the abdomen, including the | ||
| liver with functionality independent of the | ||
| MRI equipment vendor. | ||
| Software application intended to display and | ||
| visualize 2D multi-slice, spin-echo MR data | ||
| sets encompassing the abdomen. The user | ||
| may process, and review DICOM 3.0 compliant | ||
| datasets within the system and/or across | ||
| computer networks. | ||
| Design: MR | ||
| Relaxometry | T1, iron-corrected T1 (cT1) and T2* mapping. | T1, iron-corrected T1 (cT1) and T2* mapping. |
| Design: Liver Fat | ||
| Quantification | Utilizes MR images that exploit the | |
| difference in resonance frequencies | ||
| between hydrogen nuclei in water and | ||
| triglyceride fat using the three point DIXON | ||
| method. | Utilizes MR images that exploit the difference | |
| in resonance frequencies between hydrogen | ||
| nuclei in water and triglyceride fat using the | ||
| three point DIXON method. | ||
| Design: Parametric Maps | Iron corrected T1 (cT1), T2* and triglyceride fat (also known as Proton Density Fat Fraction (PDFF)) parametric maps are supported. | Iron corrected T1 (cT1), T2* and triglyceride fat (also known as Proton Density Fat Fraction (PDFF)) parametric maps are supported. |
| Design: Visualisation | Iron corrected T1 (cT1) displayed using LMS colourmap, designed to have maximum contrast on liver parenchymal tissue. | Iron corrected T1 (cT1) displayed using LMS grayscale colourmap. |
| Design: Region of Interest (ROI) | Median and interquartile range measurements created from a cross sectional slice of liver tissue. For each parametric map, statistics from multiple Regions of Interest (ROIs) – potentially placed across multiple slices – are summarised. | Mean, median, standard deviation, interquartile range measurements created from a cross sectional slice of liver tissue. |
| Design: Supported Modalities | DICOM 3.0 compliant MR data from GRE Echo and MOLLI acquisition protocols. | DICOM 3.0 compliant MR data from GRE Echo and MOLLI acquisition protocols. |
| Design: Reporting | Liver quantification images and analysis collated in a report. | Liver quantification images and analysis collated in a report. |
| Performance | Validated with phantom scans, synthetic raw data and volunteer scans covering a range of physiological values for cT1, T2* and PDFF. | Validated with volunteer and phantom scans. |
| Supported Systems | Validated across all supported manufacturers and field strengths. | Validated on Siemens Skyra (3T). |
| Standards | IEC 62304, DICOM 3.0, ISO 14971, ISO 13485 | IEC 62304, DICOM |
| Operating System | Mac OS | Microsoft Windows |
| Materials | Not applicable, standalone software. | Not applicable, standalone software. |
| Biocompatibility | Not applicable, standalone software. | Not applicable, standalone software. |
| Sterility | Not applicable, standalone software. | Not applicable, standalone software. |
| Electrical Safety | Not applicable, standalone software. | Not applicable, standalone software. |
| Mechanical Safety | Not applicable, standalone software. | Not applicable, standalone software. |
| Chemical Safety | Not applicable, standalone software. | Not applicable, standalone software. |
| Thermal Safety | Not applicable, standalone software. | Not applicable, standalone software. |
| Radiation Safety | Not applicable, standalone software. | Not applicable, standalone software. |
Device Comparison Table
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Image /page/6/Picture/4 description: The image shows the logo for Perspectum Diagnostics. The word "Perspectum" is written in a bold, dark gray font. Below it, the word "Diagnostics" is written in a lighter gray font. To the right of the words is a colorful circular logo with yellow, blue, green, and pink colors.
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In conclusion, the subject device does not result in any new potential safety risk and performs in accordance with its intended use as well as comparatively with the intended use of the chosen predicate.
8. Performance Data
Introduction
Substantial equivalence performance testing will consist of a head-to-head evaluation of the subject and predicate devices' ability to measure (corrected) T1, T2* and PDFF using phantoms as well as in-vivo volunteer data.
For in-vivo performance data please see
For each of the comparisons, the following will be calculated:
- ട Mean difference in T1/ T2* and PDFF (magnitude of the bias)
- Standard deviation
- ල Bland-Altman 95% limits of agreement
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ි Slope of bias
Phantom
The performance of LMSv2, as summarised in the tables below demonstrates that:
- o The MOLLI-based T1 measurement produced by LMSv2 is consistent with the literature-reported underestimation of ground truth T1 using MOLLI techniques 1,2.
- LiverMultiScan (LMSv2) measurement of T2* is accurate over the expected physiological range of values.
- o LiverMultiScan (LMSv2) measurement of PDFF is accurate over the expected physiological range of values.
| Phantom
metric | Accuracy
95% CI Limits of Agreement
Performance metric |
|-------------------|--------------------------------------------------------------|
| T1 | 19-25% lower than ground truth |
| T2* | +/- 2ms |
| PDFF 1 Piechnik et al. (2010) Journal of Cardiovascular Magnetic Resonance 12:69
2 Puntmann et al. (2013) Journal of Cardiovascular Magnetic Resonance 15(Suppl 1):E18
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In Vivo
The in vivo performance testing of LMSv2, as summarised in the table below demonstrates that:
- LiverMultiScan (LMSv2) measurement of cT1 is highly repeatable. o
- o LiverMultiScan (LMSv2) measurement of cT1 is reproducible between systems.
- LiverMultiScan (LMSv2) measurement of T2* is highly repeatable.
- o LiverMultiScan (LMSv2) measurement of T2* is reproducible between systems at the same field strength.
- LiverMultiScan (LMSv2) measurement of PDFF is highly repeatable.
- LiverMultiScan (LMSv2) measurement of PDFF is reproducible between systems.
| Volunteer
metric | Repeatability
95% Cl Limits of Agreement
Performance metric | Reproducibility
95% CI Limits of Agreement
Performance metric |
|---------------------|-------------------------------------------------------------------|---------------------------------------------------------------------|
| cT1 | +/- 60ms | +/- 120ms |
| T2* | +/- 7ms | +/- 10ms |
| PDFF | +/- 1% | +/- 2% |
As demonstrated in the table below, the variation introduced by operator reading (use of LMSv2) is well within the proscribed acceptance criteria. There is only minor additional variation introduced by having two readers read the same study compared to the same reader performing a second analysis blinded.
| Volunteer
metric | Intra-operator
95% CI Limits of Agreement
Performance metric | Inter-operator
95% CI Limits of Agreement
Performance metric |
|---------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|
| cT1 | +/- 18ms | +/- 25ms |
| T2* | +/- 3ms | +/- 4ms |
| PDFF | +/- 1% | +/- 1.1% |
Substantial Equivalence
The substantial equivalence testing of LMSv2 versus its predicate device, LMSv1, is summarised in the tables below.
Phantom measurements show that LMSv2 produces T1 and T2* values within 1ms of the predicate (negligible difference). PDFF is within 1% of the predicate where PDFF